The Observer - Pfizer set for UK Viagra go-ahead within a month
By Sarah Ryle
Sunday August 23, 1998
Viagra could be legally available in Europe within a month
following a crucial meeting of drug industry regulators in
London tomorrow.
The meeting, attended by Pfizer, the manufacturer of the
blockbuster impotence drug, aims to draft an approval for a
licence to market Viagra across Europe.
Representatives from all the member states' governments
and/or national regulatory bodies have been invited. They
are expected to forward their draft to the European
Commission soon afterwards.
The European Commissioner in charge of drugs licensing,
Martin Bangemann, would give Pfizer the green light about
three weeks later.
Pfizer is already gearing up for a massive launch following
an initial positive response from scientists who advise the
European Medicines Evaluation Agency (EMEA).
If the response to Viagra in the US is anything to go by - it
has become the fastest-selling drug in history - sales will
accelerate at a phenomenal rate.
US doctors have issued 3.5 million prescriptions for Viagra
since it was approved by the Food and Drug Administration
on 27 March - equivalent to 23,490 prescriptions every
day.
On Wall Street, Pfizer's stock has risen from about $51 a
year ago to $105.75. Industry analysts have estimated that
sales could reach $2 billion by 1999 and $2.5bn by 2001.
The drug has also been approved in Brazil, Mexico,
Morocco and South Africa.
US sales this year are likely to be up to $850 million
according to a Pfizer presentation last month. This is despite
the fact that more than half of US health plans refuse to
reimburse policyholders for the drug - a bad sign for those
arguing that Viagra should be available on the NHS in the
UK.
At the recent British Medical Association conference, one
doctor warned that Viagra could cost the NHS œ1bn every
year if each of the one in 10 men who are impotent are
prescribed the drug.
But Pfizer is anticipating annual UK sales in the region of
œ100m in five years' time. However, the US-based
company bases this prediction on Viagra winning regulatory
approval as a primary healthcare drug - a medicine that
GPs can prescribe.
It is unlikely ever to become available over the counter
because of the need to check patients' general health. The
Government has indicated that it might restrict prescribing to
consultant urologists. This sparked a survey by the British
Association of Urological Surgeons, which found that 93
per cent thought GPs should be allowed to prescribe
Viagra.
reports.guardian.co.uk |
